3D-printing on trend: Aprecia and Cycle sign orphan drug deal

Three-dimensional printing technology is attracting increased attention from the US FDA say Aprecia and Cycle, which have announced a partnership to develop 3D-printed orphan drugs.

Under the agreement, Aprecia Pharmaceuticals will use its ZipDose Technology platform to manufacture the drugs, and Cycle Pharmaceuticals will be responsible for developing the active ingredients, managing the clinical trial proofs, and commercialising the candidates.

3D printing – also known as additive manufacturing – involves using a digital model to guide the successive deposition of material to form an object.

The ZipDose platform three-dimensionally prints multiple layers of powder blend using an aqueous fluid to produce a porous, water-soluble matrix, which Aprecia said can be easily disintegrated.

The technology “creates premeasured, spill-proof unit-doses designed to disintegrate in the mouth with just a sip of liquid,” ​said the firm, adding that this fast-melt characteristic can assist with dysphagia (swallowing difficulties).

According to Cycle CEO Antonio Benedetti, the technology achieves higher active ingredient doses in a single tablet than other technologies on the market.

“This is particularly relevant to rare disease patients who typically have a high pill burden,” ​he told us.

Where and how much?​

The 3D-printed drug products will be manufactured at Aprecia’s facility at Blue Ash, Ohio, US.

Aprevia first leased the Forest Labs site in 2013, when it announced​ the facility would serve as its 3D-printing technology hub.

“The goal of this partnership is to apply 3DP technology to improve the quality of life for patients….therefore our products must be accessible, and that means they must be priced appropriately,” ​said the spokesperson.

“We hope we can help several rare disease patient groups over the coming months and years as this technology continues to gain momentum,” ​he added.

US FDA support​

In 2015, the US FDA approved​ Aprecia’s Spritam (levetiracetam) tablets – the first 3D printed prescription to receive US approval – to treat partial onset seizures.

Earlier this week, the US Food and Drug Administration (FDA) published​ a perspective on 3D-printed pharmaceutical drugs, with the aim of identifying the industry’s 3D-printed drug concerns​.

Cycle told us it is encouraged by the Agency’s support of 3D-printed manufacturing technology.

“The Aprecia/Cycle team is looking forward to working closely with regulators to ensure an efficient proof and approval of these needed drugs, so that patients can benefit as swiftly as possible,” ​said Benedetti.

“Both Cycle and Aprecia have received drug approvals from the FDA, and we will therefore work together on regulatory matters,” ​he added.